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. 2020 Dec 24;2020(12):CD008367. doi: 10.1002/14651858.CD008367.pub4

Tantipong 2008.

Study characteristics
Methods Study design: single‐centre RCT with 2 parallel groups
Location: Thailand
Number of centres: 1 tertiary care university hospital
Study period: January 2006 through March 2007
Funding source: Thailand Research Fund and Faculty of Medicine Siriraj Hospital
Participants Inclusion criteria: eligible patients were adults aged ≧ 18 years who were hospitalised in intensive care units (36 beds) or general medical wards (240 beds) at Siriraj Hospital and who received mechanical ventilation.
Exclusion criteria: patients who had pneumonia at enrolment or who had a chlorhexidine allergy
Number randomised: 207
Number evaluated: 207 (110 participants received mechanical ventilation for > 48 hours)
‐ Experimental group: n = 102; age: 56.5 ± 20.1; M/F: 50/52; mean APACHE II score: 16.7 ± 7.9
‐ Control group: n = 105; age: 60.3 ± 19.1; M/F: 51/54; mean APACHE II score: 18.2 ± 8.1
Participants' demographic characteristics between groups did not differ significantly.
Interventions Comparison: toothbrush + chlorhexidine vs toothbrush + placebo
Experimental group (n = 102): received oral care 4 times a day with brushing the teeth, suctioning any oral secretions, and rubbing the oropharyngeal mucosa with 15 mL of a 2% chlorhexidine solution, until their endotracheal tubes were removed.
Control group (n = 105): same oral care procedure with normal saline solution
Outcomes 1. Incidence of VAP
2. Number of cases of VAP per 1000 ventilator days
3. Incidence of VAP for participants who received mechanical ventilation for > 2 days
4. Overall mortality
5. Mean days of mechanical ventilation (mean ± SD)
6. Rate of irritation of oral mucosa
Notes Sample size calculation: estimated that 108 participants required in each group to give 80% power to detect a 50% decrease in VAP with 5% Type 1 error
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "...randomized...by stratified randomization according to sex and hospital location of eligible patient"
Allocation concealment (selection bias) Unclear risk Not mentioned and probably not done
Blinding of participants and personnel (performance bias)
All outcomes High risk Not blinded as chlorhexidine solution had different odour and taste from saline
Blinding of outcome assessment (detection bias)
All outcomes Low risk The assessors who determined whether a participant developed pneumonia were unaware of the participant's study group assignment.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk All randomised participants included in outcome evaluation but only 53% of participants on ventilators for > 2 days and therefore at risk of VAP
Selective reporting (reporting bias) Unclear risk Planned outcome VAP but not all participants at risk and information unclear. Mortality reported
Other bias Unclear risk Only 60% of study participants received ventilation in ICU and only 53% of participants received mechanical ventilation for > 48 hours. Likely that nursing care protocols were different in general medical wards compared to ICUs